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The Psychoactive Trials Group at the Centre for Affective Disorders is undertaking controlled clinical trials with psychedelics and related compounds such as psilocybin, 5-MeO-DMT and MDMA. We are studying psychedelic therapies for different conditions including treatment-resistant depression and posttraumatic stress disorder. These trials are led by Dr James Rucker and Professor Allan Young.

The aim of these trials is to explore the safety and effectiveness of these therapies. In addition, we are investigating how these new approaches could be realised in healthcare systems, developing therapist training programs and training resources for wider implementation, if they are licensed.

At the Institute of Psychology, Psychiatry & Neuroscience, King’s College London, we are experts in this field. Our combination of specialist clinical teams, research infrastructure and a diverse partnership portfolio means we are well-equipped to test and develop novel therapeutics.

In 2022, together with South London and Maudsley NHS Foundation Trust and COMPASS Pathways, we launched the Centre for Mental Health Research and Innovation to accelerate psychedelic research.

The funding for our trials comes from a mixture of commercial and non-commercial funders.

If you’d like to apply for one of our ongoing trials please click on the following Project tab.

People

Laith  Alexander

Clinical Lecturer in Psychiatry and Experimental Medicine

Famia Askari

Psychiatrist

Michelle Baker Jones

Integrative Psychotherapeutic Counsellor

Catherine Bird

Senior Clinical Trials Manager

Steve  Burchell

Psychotherapist

Matt Butler

Wellcome Doctoral Clinical Research Fellow

Projects

Image missing an alt value
BPL-003-201 Study - 5-MeO-DMT Therapy for Treatment Resistant Depression

BPL-003-201 Study - 5-MeO-DMT Therapy for Treatment Resistant Depression

Image missing an alt value
COMP006 Study - COMP360 (psilocybin) for treatment resistant depression

A phase 3 trial investigating psilocybin therapy for treatment resistant depression

Image missing an alt value
Psilocybin in Depression Resistant to Standard Treatments (PsiDeR) Study

This is a phase 2, randomised, placebo-controlled trial investigating psilocybin therapy as a treatment for treatment resistant depression.

News

Largest trial to date shows that psilocybin reduces depression symptoms

A new multicentre clinical trial led by COMPASS Pathways across 22 international sites, including the Institute of Psychiatry, Psychology & Neuroscience...

Spilled medication and bottle

New partnership launched with SLaM and COMPASS Pathways

The Institute for Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London has announced a new partnership to launch The Centre for Mental...

Partnership

Psilocybin, in 10mg or 25mg doses, has no short- or long-term detrimental effects in healthy people

Psilocybin can be safely administered at doses of either 10mg or 25mg to up to six participants simultaneously.

drug bottles hero

Background

History of human use of psychedelics

In the past, psychedelics like psilocybin, mescaline and ayahuasca have been used by different cultures around the world in ceremonial, spiritual and ‘healing’ rituals. Some continue to be used legally by the descendants of those indigenous cultures. Such rituals come with a rich and important history that inform about their role and use.

History of psychedelics in psychiatry

Prior to 1970 the classical psychedelics psilocybin, mescaline and d-lysergic acid diethylamide (LSD) were used in psychiatry as part of an ongoing process of psychotherapy for resistant forms of depression, anxiety and addictions. Research at that time, which was suboptimal by modern standards, suggested that they were helpful for some people when given within a medically controlled and psychologically supportive context.

history psychedelics

    After 1970, LSD, psilocybin and mescaline were legally designated ‘Schedule 1’ substances, meaning that they could not be prescribed by medical doctors outside of authorised research. Funding for research dried up in the wake of hardening socio-political attitudes towards psychoactive drugs in general. Consequently, this area of clinical research stopped without a clear view about whether psychedelic therapy was safe and effective.

    Since 2000, there has been a slow but steady resurgence of clinical research interest into psychedelics and related compounds such as MDMA and ketamine. A growing number of clinical trials have been published. Here at KCL, we are part of this research.

    The need for new paradigms of treatment in psychiatry

    Whilst many patients with mental health problems get better with available treatments, a subgroup of people do not even though they try many different forms of treatment. This is sometimes called ‘treatment resistance’. This can lead to a variety of other problems that seriously impact on patients and the people around them. Treatment options are often limited and come with troublesome side effects or stigma. Therefore, new paradigms of treatment are needed and clinical research of new treatments is important. Psychedelic therapy may be a new paradigm of treatment, but this needs to be tested in clinical trials.

    Oversight of our trials

    All of our clinical trials are authorised by the National Research Ethics Committee, who are a group of professionals and members of the public whose job is to scrutinise and ensure the rights and wellbeing of participants in clinical trials. All of our clinical trials are registered with the Medicine’s and Healthcare Products Regulatory Agency, who are a government funded body whose job is to ensure that treatment development and research is being conducted according to internationally agreed standards with interventions manufactured to proper standards. All of our trials are regularly reviewed by the Sponsors and the Ethics Committees, who are able to halt a trial if they think it is no longer appropriate for it to continue.

    Completed Trials

    The effects of psilocybin on cognitive function in healthy participants

    In partnership with COMPASS Pathways researchers from King’s College London have established that psilocybin can be safely administered at doses of either 10mg or 25mg to up to six participants simultaneously.

    The trial is now finished and results were published in The Journal of Psychopharmacology in March 2022. They represent an essential first step in demonstrating the safety and feasibility of psilocybin for use within controlled settings alongside talking therapy as a potential treatment for a range of mental health conditions.

    Status

    Completed, not recruiting

    Participants

    Adults

    Clinical area

    Healthy participants

    Intervention

    Psilocybin

    Recruitment period

    2018-2020

    Funder

    Compass Pathways

    Sponsor

    Compass Pathways

     

    The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD) Study

    King’s College London were part of a multi-centre trial led by COMPASS Pathways that is called P-TRD. The trial was conducted across 22 sites in 10 countries from Europe and the US. Adults with treatment resistant depression were given psilocybin at a dose of 25 mg, 10 mg, or 1 mg. The drug was administered together with psychological support and researchers measured changes in depression symptoms.

    Status

    Completed, not recruiting

    Participants

    Adults

    Clinical area

    Treatment resistant depression

    Intervention

    Psilocybin therapy

    Recruitment period

    2020-2021

    Funder

    Compass Pathways

    Sponsor

    Compass Pathways

     

    An Exploratory Open-Label, Phase 1b, Ascending Dose Study to Evaluate the Effects of Oral 3 [2 (dimethylamino)ethyl]-1h-indol-4-yl Dihydrogen Phosphate (Psilocybin, BPL PSILO) on Cognition in Patients with Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)

    Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA) are debilitating and there are few treatment options. With  funding from Beckley PsyTech researchers from King’s investigated  the efficacy of psilocybin at three doses for treating these headache attacks, particularly looking at its impact on thought processes.

    Status

    Completed, not recruiting

    Participants

    Adults

    Clinical area

    SUNHA

    Intervention

    3 doses of psilocybin

    Recruitment period

    2022

    Funder

    Beckley PsyTech

    Sponsor

    Beckley PsyTech

     

    A Double-Blind, Randomized, Phase 1, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal 5 Methoxy N,N-dimethyltryptamine (5-MeO-DMT) in Healthy Subjects

    In partnership with Beckley PsyTech, King’s researchers evaluated the safety and tolerability of the psychedelic 5 Methoxy N,N-dimethyltryptamine (5-MeO-DMT) which is found in a variety of plant species and secreted by one species of toad. It was administered nasally to healthy participants at one dosage and researchers assessed the percentage of participants that experienced any unfavourable and unintended signs, alongside various measures to assess what is happening to the drug when it is taken.

    Status

    Completed, not recruiting

    Participants

    Adults

    Clinical area

    Healthy participants

    Intervention

    5-Methoxy-N,N-Dimethyltryptamine

    Recruitment period

    2021 – 2022

    Funder

    Beckley PsyTech

    Sponsor

    Beckley PsyTech

      

    Publications:

    https://journals.sagepub.com/doi/full/10.1177/02698811211064720

     

    An Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA- Assisted Psychotherapy with an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects with Posttraumatic Stress Disorder

    With support from the Multidisciplinary Association of Psychedelic Studies (MAPS) we trialled MDMA therapy for PTSD for veterans. 

    Status

    Completed, not recruiting

    Participants

    Adults

    Clinical area

    PTSD

    Intervention

    MDMA

    Recruitment period

    2022 – 2023

    Funder

    MAPS

    Sponsor

    MAPS

     

    The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder

    With support from Compass Pathways, we explored the safety and tolerability of of COMP360 (psilocybin) given alongside psychological support to participants suffering from post-traumatic stress disorder. This trial was undertaken alongside colleagues in the United States.

    Status

    Completed, not recruiting

    Participants

    Adults

    Clinical area

    PTSD

    Intervention

    Psilocybin

    Recruitment period

    2022 – 2023

    Funder

    Compass Pathways

    Sponsor

    Compass Pathways

     

    An Open-Label, Phase 2a Single Dose Study of 5-MeO-DMT in Patients With Alcohol Use Disorder

    With the support of Beckley PsyTech we trialled 5-MeO-DMT given with structured psychological support for alcohol use disorder. 5-MeO-DMT is a short-acting psychedelic drug, which means that it induces an altered state of consciousness that can be characterised by mystical experiences, strong emotions, visions and distorted perceptions.

    Status

    Completed, not recruiting

    Participants

    Adults

    Clinical area

    Alcohol use disorder

    Intervention

    5-MeO-DMT with Structured Psychological Support

    Recruitment period

    2023-24

    Contact

    AUD-5MEODMT@kcl.ac.uk

    Funder

    Beckley PsyTech

    Sponsor

    Beckley PsyTech

     

    With support from Transcend Therapeutics, we explored the safety and efficacy of methylone treatment in patients suffering from post-traumatic stress disorder.

    Status

    Completed, not recruiting

    Participants

    Adults

    Clinical area

    Post-traumatic stress disorder

    Intervention

    Methylone therapy

    Recruitment period

    2024

    Contact

    methylone@kcl.ac.uk

    Funder

    Transcend Therapeutics

    Sponsor

    Transcend Therapeutics

    People

    Laith  Alexander

    Clinical Lecturer in Psychiatry and Experimental Medicine

    Famia Askari

    Psychiatrist

    Michelle Baker Jones

    Integrative Psychotherapeutic Counsellor

    Catherine Bird

    Senior Clinical Trials Manager

    Steve  Burchell

    Psychotherapist

    Matt Butler

    Wellcome Doctoral Clinical Research Fellow

    Projects

    Image missing an alt value
    BPL-003-201 Study - 5-MeO-DMT Therapy for Treatment Resistant Depression

    BPL-003-201 Study - 5-MeO-DMT Therapy for Treatment Resistant Depression

    Image missing an alt value
    COMP006 Study - COMP360 (psilocybin) for treatment resistant depression

    A phase 3 trial investigating psilocybin therapy for treatment resistant depression

    Image missing an alt value
    Psilocybin in Depression Resistant to Standard Treatments (PsiDeR) Study

    This is a phase 2, randomised, placebo-controlled trial investigating psilocybin therapy as a treatment for treatment resistant depression.

    News

    Largest trial to date shows that psilocybin reduces depression symptoms

    A new multicentre clinical trial led by COMPASS Pathways across 22 international sites, including the Institute of Psychiatry, Psychology & Neuroscience...

    Spilled medication and bottle

    New partnership launched with SLaM and COMPASS Pathways

    The Institute for Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London has announced a new partnership to launch The Centre for Mental...

    Partnership

    Psilocybin, in 10mg or 25mg doses, has no short- or long-term detrimental effects in healthy people

    Psilocybin can be safely administered at doses of either 10mg or 25mg to up to six participants simultaneously.

    drug bottles hero

    Background

    History of human use of psychedelics

    In the past, psychedelics like psilocybin, mescaline and ayahuasca have been used by different cultures around the world in ceremonial, spiritual and ‘healing’ rituals. Some continue to be used legally by the descendants of those indigenous cultures. Such rituals come with a rich and important history that inform about their role and use.

    History of psychedelics in psychiatry

    Prior to 1970 the classical psychedelics psilocybin, mescaline and d-lysergic acid diethylamide (LSD) were used in psychiatry as part of an ongoing process of psychotherapy for resistant forms of depression, anxiety and addictions. Research at that time, which was suboptimal by modern standards, suggested that they were helpful for some people when given within a medically controlled and psychologically supportive context.

    history psychedelics

      After 1970, LSD, psilocybin and mescaline were legally designated ‘Schedule 1’ substances, meaning that they could not be prescribed by medical doctors outside of authorised research. Funding for research dried up in the wake of hardening socio-political attitudes towards psychoactive drugs in general. Consequently, this area of clinical research stopped without a clear view about whether psychedelic therapy was safe and effective.

      Since 2000, there has been a slow but steady resurgence of clinical research interest into psychedelics and related compounds such as MDMA and ketamine. A growing number of clinical trials have been published. Here at KCL, we are part of this research.

      The need for new paradigms of treatment in psychiatry

      Whilst many patients with mental health problems get better with available treatments, a subgroup of people do not even though they try many different forms of treatment. This is sometimes called ‘treatment resistance’. This can lead to a variety of other problems that seriously impact on patients and the people around them. Treatment options are often limited and come with troublesome side effects or stigma. Therefore, new paradigms of treatment are needed and clinical research of new treatments is important. Psychedelic therapy may be a new paradigm of treatment, but this needs to be tested in clinical trials.

      Oversight of our trials

      All of our clinical trials are authorised by the National Research Ethics Committee, who are a group of professionals and members of the public whose job is to scrutinise and ensure the rights and wellbeing of participants in clinical trials. All of our clinical trials are registered with the Medicine’s and Healthcare Products Regulatory Agency, who are a government funded body whose job is to ensure that treatment development and research is being conducted according to internationally agreed standards with interventions manufactured to proper standards. All of our trials are regularly reviewed by the Sponsors and the Ethics Committees, who are able to halt a trial if they think it is no longer appropriate for it to continue.

      Completed Trials

      The effects of psilocybin on cognitive function in healthy participants

      In partnership with COMPASS Pathways researchers from King’s College London have established that psilocybin can be safely administered at doses of either 10mg or 25mg to up to six participants simultaneously.

      The trial is now finished and results were published in The Journal of Psychopharmacology in March 2022. They represent an essential first step in demonstrating the safety and feasibility of psilocybin for use within controlled settings alongside talking therapy as a potential treatment for a range of mental health conditions.

      Status

      Completed, not recruiting

      Participants

      Adults

      Clinical area

      Healthy participants

      Intervention

      Psilocybin

      Recruitment period

      2018-2020

      Funder

      Compass Pathways

      Sponsor

      Compass Pathways

       

      The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD) Study

      King’s College London were part of a multi-centre trial led by COMPASS Pathways that is called P-TRD. The trial was conducted across 22 sites in 10 countries from Europe and the US. Adults with treatment resistant depression were given psilocybin at a dose of 25 mg, 10 mg, or 1 mg. The drug was administered together with psychological support and researchers measured changes in depression symptoms.

      Status

      Completed, not recruiting

      Participants

      Adults

      Clinical area

      Treatment resistant depression

      Intervention

      Psilocybin therapy

      Recruitment period

      2020-2021

      Funder

      Compass Pathways

      Sponsor

      Compass Pathways

       

      An Exploratory Open-Label, Phase 1b, Ascending Dose Study to Evaluate the Effects of Oral 3 [2 (dimethylamino)ethyl]-1h-indol-4-yl Dihydrogen Phosphate (Psilocybin, BPL PSILO) on Cognition in Patients with Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)

      Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA) are debilitating and there are few treatment options. With  funding from Beckley PsyTech researchers from King’s investigated  the efficacy of psilocybin at three doses for treating these headache attacks, particularly looking at its impact on thought processes.

      Status

      Completed, not recruiting

      Participants

      Adults

      Clinical area

      SUNHA

      Intervention

      3 doses of psilocybin

      Recruitment period

      2022

      Funder

      Beckley PsyTech

      Sponsor

      Beckley PsyTech

       

      A Double-Blind, Randomized, Phase 1, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal 5 Methoxy N,N-dimethyltryptamine (5-MeO-DMT) in Healthy Subjects

      In partnership with Beckley PsyTech, King’s researchers evaluated the safety and tolerability of the psychedelic 5 Methoxy N,N-dimethyltryptamine (5-MeO-DMT) which is found in a variety of plant species and secreted by one species of toad. It was administered nasally to healthy participants at one dosage and researchers assessed the percentage of participants that experienced any unfavourable and unintended signs, alongside various measures to assess what is happening to the drug when it is taken.

      Status

      Completed, not recruiting

      Participants

      Adults

      Clinical area

      Healthy participants

      Intervention

      5-Methoxy-N,N-Dimethyltryptamine

      Recruitment period

      2021 – 2022

      Funder

      Beckley PsyTech

      Sponsor

      Beckley PsyTech

        

      Publications:

      https://journals.sagepub.com/doi/full/10.1177/02698811211064720

       

      An Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA- Assisted Psychotherapy with an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects with Posttraumatic Stress Disorder

      With support from the Multidisciplinary Association of Psychedelic Studies (MAPS) we trialled MDMA therapy for PTSD for veterans. 

      Status

      Completed, not recruiting

      Participants

      Adults

      Clinical area

      PTSD

      Intervention

      MDMA

      Recruitment period

      2022 – 2023

      Funder

      MAPS

      Sponsor

      MAPS

       

      The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder

      With support from Compass Pathways, we explored the safety and tolerability of of COMP360 (psilocybin) given alongside psychological support to participants suffering from post-traumatic stress disorder. This trial was undertaken alongside colleagues in the United States.

      Status

      Completed, not recruiting

      Participants

      Adults

      Clinical area

      PTSD

      Intervention

      Psilocybin

      Recruitment period

      2022 – 2023

      Funder

      Compass Pathways

      Sponsor

      Compass Pathways

       

      An Open-Label, Phase 2a Single Dose Study of 5-MeO-DMT in Patients With Alcohol Use Disorder

      With the support of Beckley PsyTech we trialled 5-MeO-DMT given with structured psychological support for alcohol use disorder. 5-MeO-DMT is a short-acting psychedelic drug, which means that it induces an altered state of consciousness that can be characterised by mystical experiences, strong emotions, visions and distorted perceptions.

      Status

      Completed, not recruiting

      Participants

      Adults

      Clinical area

      Alcohol use disorder

      Intervention

      5-MeO-DMT with Structured Psychological Support

      Recruitment period

      2023-24

      Contact

      AUD-5MEODMT@kcl.ac.uk

      Funder

      Beckley PsyTech

      Sponsor

      Beckley PsyTech

       

      With support from Transcend Therapeutics, we explored the safety and efficacy of methylone treatment in patients suffering from post-traumatic stress disorder.

      Status

      Completed, not recruiting

      Participants

      Adults

      Clinical area

      Post-traumatic stress disorder

      Intervention

      Methylone therapy

      Recruitment period

      2024

      Contact

      methylone@kcl.ac.uk

      Funder

      Transcend Therapeutics

      Sponsor

      Transcend Therapeutics

      Group leads